Recruiting

TKI vs. Non-TKI

Sponsor:

University of Rochester NCORP Research Base

Code:

NCT07638007

Conditions

Disease/Condition Name Cancer-related Cognitive Dysfunction

Chronic Lymphocytic Leukemia (CLL)

Chronic Myeloid Leukemia, BCR-ABL1 Positive

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

This study examines whether there are differences in brain health or well-being in patients receiving TKI therapy for leukemia compared to individuals who do not receive TKI therapy.

Conditions

Disease/Condition Name Cancer-related Cognitive Dysfunction

Chronic Lymphocytic Leukemia (CLL)

Chronic Myeloid Leukemia, BCR-ABL1 Positive

Study ID

NCT07638007

Start date

Nov 21, 2025

Status verified date

Jun, 2026

Completion date

Feb 28, 2029

Anticipated

Primary completion date

Feb 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • TKI RECIPIENTS: Participants must have a diagnosis of CML or CLL
  • TKI RECIPIENTS: Participants must be scheduled to receive their first dose of TKI therapy for CML or CLL within 30 days or have received their first dose of TKI therapy for CML or CLL within the previous 30 days
  • TKI RECIPIENTS: Participants must be ≥ 18 years of age
  • TKI RECIPIENTS: Participants must be able to speak and read English
  • TKI RECIPIENTS: Participants must be able to understand and willing to sign an informed consent document
  • CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be ≥ 18 years of age
  • CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be able to speak and read English
  • CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be able to understand and willing to sign an informed consent document
  • CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Each participant must be matched to a TKI recipient participant based on sex and age ±5 years (i.e., must be no more than 5 years older or younger than the TKI recipient participant)

Exclusion Criteria:

  • Participants must have no history of metastatic cancer, primary brain tumor, or brain irradiation
  • Participants must have no history of TKI therapy
  • Participants must have no history of cytotoxic chemotherapy, immune checkpoint inhibitor therapy, hormonal therapy, biologic therapy, radiotherapy within the past 5 years. However, permitted treatments include prior use of hydroxyurea for the treatment of CML or CLL as well as treatment with obinutuzumab or rituximab concurrent with TKI therapy for CLL
  • Participants must have no history of stroke within the past year and no remaining cognitive symptoms from any stroke prior to the past year
  • Participants must have no history of head trauma with loss of consciousness within the year prior to consent
  • Participants must have no diagnosis of dementia or severe neurodegenerative disease impairing daily functioning
  • Participants must have no psychiatric condition that led to hospitalization within the past year
  • Participants must not be currently pregnant
  • Participants must not be colorblind based on self-report
  • Participants must not be study staff who have previously viewed or administered the objective cognitive function measures (e.g., CANTAB)

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational group I

TKI recipients complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study.

Observational group II

Cancer-free individuals complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study.

Primary outcome measure

  • Subjective cognitive performance [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Ashley Mack, MS

585-275-1090URCC_24060@urmc.rochester.edu

Locations

University of Rochester NCORP Research Base

Recruiting

Rochester, New York, United States, 14642

Contacts

Ashley Mack

585 - 275 - 1361URCC_24060@urmc.rochester.edu

Principal Investigator:

Karen Mustian, PhD

More Information

Sponsor

University of Rochester NCORP Research Base

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Rochester NCORP Research Base on 2026-06-10.